The Application of Sling Exercise Training in People With Chronic Stroke

Chronic Stroke Clinical Trial

Official title:

The Application of Sling Exercise Training in People With Chronic Stroke - The Emphasis of Core Muscle Control on Gait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352009
• Other study ID #: YM111016F
• Status: Completed
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: November 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this single-blinded, randomized controlled study aims to investigate the effects of sling exercise training (SET) for core muscle on gait performance in people with chronic stroke.

Description:

Background and purpose: Balance and gait performance are often impaired in people post stroke. Evidence showed positive correlations between trunk control and balance and walking ability. Previous studies applying core muscle training reported positive effects on improving trunk control and sitting balance among patients with chronic stroke, but benefits on standing balance and gait performance remain undetermined. Sling exercise training (SET) has been suggested for improving core muscle stability and strength in people with stroke. However, studies about effects of SET on gait performance in stroke populations are limited. Therefore, the present study aims to investigate the effects of SET for core muscle on gait performance in people with chronic stroke. Methods: Thirty-eight individuals with chronic stroke will be recruited and assigned to one of the two groups by randomization, sling exercise training group and conventional training group. The training is 30 minutes per session, 3 sessions per week for total of 4 weeks. Gait performance is the primary outcome to include gait speed, stride length, single leg support time and temporal and spatial symmetry measured by GAITRite® System. Secondary outcomes include balance, timed up-and-go (TUG) test and trunk performance. All outcomes will be assessed before, after the 4-week training program and at 4-week follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Stroke after onset = 6 months
• Trunk impairment scale (TIS) score = 21 at baseline
• Brunnstrome stage = IV over the affected lower extremity
• Ability to independently walk for 10 meters with or without assistive devices
• Intact cognition with mini-mental state examination (MMSE) = 24

Exclusion Criteria:

• Any other significant musculoskeletal disorder, neurological disease or cardiovascular disease that may affect the participation in this study.
• Vision or language deficit that may affect participating in this study.

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Other:
• Sling exercise training
All participants will receive exercise training for 30 min/ session, 3 sessions/ week for 4 weeks (a total of 12 training sessions). The training includes 20 min of sling exercise training and 10 min treadmill training.
• Conventional balance training
All participants will receive exercise training for 30 min/ session, 3 sessions/ week for 4 weeks (a total of 12 training sessions). The training includes 20 min of balance exercise training and 10 min treadmill training.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait performance: change in gait speed	Using GAITRite® system to evaluate gait speed in comfortable speed	Change from baseline gait speed at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Primary	Gait performance: change in stride length	Using GAITRite® system to evaluate stride length in comfortable speed	Change from baseline stride length at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Primary	Gait performance: change in single leg support time	Using GAITRite® system to evaluate single leg support time in comfortable speed	Change from baseline single leg support time at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Primary	Gait performance: change in temporal and spatial symmetry index	Using GAITRite® system to evaluate temporal and spatial symmetry index in comfortable speed	Change from baseline temporal and spatial symmetry index at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Balance: change in movement velocity	Using Balance Master®: Limits of Stability test to assess movement velocity during moving center of pressure to the highlighted target.	Change from baseline movement velocity at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Balance: change in directional control	Using Balance Master®: Limits of Stability test to assess directional control during moving center of pressure to the highlighted target.	Change from baseline directional control at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Balance: change in maximal excursion	Using Balance Master®: Limits of Stability test to assess maximal excursion during moving center of pressure to the highlighted target.	Change from baseline maximal excursion at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Balance: change in one leg stance	Using Balance Master® to measure the sway under one leg standing	Change from baseline postural sway under one leg stance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Balance: change in functional balance performance	Using Berg Balance Scale (BBS) to assess functional balance performance. Berg Balance Scale is a 14-item scale which scoring 0-4 of each, ranges from 0 to 56, and higher score indicates better balance performance.	Change from baseline BBS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Change in mobility performance	Using Timed up-and-go (TUG) test to assess mobility	Change from baseline mobility performance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Change in trunk control	Using Trunk Impairment Scale (TIS) to assess ability of trunk control. The trunk impairment scale ranges from 0 to 23, and a higher scoring indicates a better trunk control.	Change from baseline TIS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Change in trunk muscle strength: trunk flexors	Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk flexors	Change from baseline strength of trunk flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Change in trunk muscle strength: trunk extensors	Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk extensors	Change from baseline strength of trunk extensors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
Secondary	Change in trunk muscle strength: trunk lateral flexors	Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk lateral flexors	Change from baseline strength of trunk lateral flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)